Statistical Methods in Biomarker and Early Clinical Development
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Overview
Predictive Subgroup/Biomarker Identification and Machine Learning Methods.- Characterize and Dichotomize a Continuous Biomarker.- Surrogate Biomarkers.- Innovative Designs for Biomarker Guided Trials.- Statistical Considerations in the Development of Companion Diagnostic Device.- Biomarker Assay Development, Qualification and Validation.- Validation of Genomic Based Assay.- Clinical Application of Molecular Features in Therapeutic Selection and Drug Development.- Big data, real-world data, and machine learning.- Design and Analysis of Clinical Pharmacology Studies.- Statistical Considerations in Proof of Concept Studies.- Safety in Early Phase Studies.- Statistical Evaluation of QT/QTc Interval Prolongation.- Phase II Dose Finding.- Pharmacometrics.
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Details
- ISBN-13: 9783030315054
- ISBN-10: 3030315053
- Publisher: Springer
- Publish Date: January 2021
- Dimensions: 9.21 x 6.14 x 0.75 inches
- Shipping Weight: 1.12 pounds
- Page Count: 348
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